US Patent and Trademark Office grants important real-time PCR patent to Roche Diagnostics
Patented process makes DNA analysis faster and easier

Roche Molecular Systems, a business unit of Roche Diagnostics, announced today that the U.S. Patent and Trademark Office has issued the Company U.S. patent No. 6,171,785 B1 ("the '785 patent") relating to methods of monitoring nucleic acid amplification reactions, such as the polymerase chain reaction (PCR).The '785-patent process was invented by Russell Higuchi, Ph.D., Associate Director of the Human Genetics Department at Roche Molecular Systems in Alameda, California. The issuance of this patent reinforces Roche's patent coverage in the area of real-time amplification, detection and quantitation, which includes both the methods of the '785 patent and the TaqMan® technology.

The '785 patent builds on U.S. patent No. 5,994,056, issued to Roche on November 30, 1999 for a dye-based, probeless process of simultaneous PCR amplification and detection. Roche holds the patent for the original PCR process, which it licenses broadly for a range of applications, including clinical diagnostic testing.

The '785 patent describes dye-based, probeless detection methods which enable the simultaneous detection and quantitation of nucleic acid amplification products during the reaction. Applications for these methods include genetics, genomics, and microbiology research. The methods also provide a fast, economical option for detection of single nucleotide polymorphisms (SNPs) for genotyping.

In early amplification processes, the DNA or RNA in the sample was amplified first and then detected in a separate step. This '785-patent process combines the two steps by including fluorescent dyes in the reaction to provide for real-time monitoring of the reaction. The researcher can observe the fluorescence increasing as the number of DNA copies increases throughout the reaction. How quickly this occurs can be directly related to the starting amount of DNA or RNA. This "real time" PCR method will dramatically reduce the time and steps needed to obtain quantitative test results.

These methods, also known as "Kinetic PCR", offer significant advantages to the diagnostic, molecular biology or microbiology laboratory in terms of efficiency and productivity. Along with the increase in speed, real-time quantitative PCR reduces the threat of contamination, as the entire test takes place in a sealed tube. In addition, Kinetic PCR-based quantitation methods provide an increase in dynamic range, which makes this process more useful for a variety of applications. The elimination of a separate detection step significantly reduces hands-on time, a major advantage for laboratories attempting to control costs while increasing output.

This patent further reinforces Roche Molecular Systems' leadership position in nucleic acid testing based on the gold standard PCR method.

Roche Molecular Systems manufactures and distributes diagnostic test kits, reagents and instrumentation based on its patented PCR technology. Applications for PCR include medical diagnostics, the human genome project, DNA sequencing, food testing, forensic identification, paternity testing, and scientific research involving DNA amplification. Roche is committed to making PCR available throughout the scientific community, and licenses it broadly for commercial applications. The '785 and '056 patents, together with related TaqMan and real time patents, are immediately available for licensure for use in clinical diagnostic applications.

"We are excited to add this new patent to our portfolio of intellectual property," stated Heiner Dreismann, President of Roche Molecular Systems. "Our program in Discovery Research has developed numerous techniques and products that facilitate the important research work being performed worldwide in genetics, genomics and pharmaceutical research."

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics, and vitamins. Roche's innovative products and services address prevention, diagnosis and treatment of diseases, thus enhancing people's well being and quality of life. Through the company's Diagnostics Division, innovative testing products and services are made available to physicians, patients, hospitals and laboratories worldwide. Roche Molecular Systems, a business unit within Roche Diagnostics, has made PCR the leading DNA probe technology in the world. PCR technology allows very minute amounts of genetic material to be amplified into billions of copies in just a few hours, thereby facilitating detection of the DNA or RNA of pathogenic organisms, even before antibodies against these organisms can be formed.